Signature Care Medicated Cold and Hot Patch

Manufacturer
Safeway | Foshan Aqua Gel Biotech Co., Ltd.,
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:45:13

Label at a glance#

ProductSignature Care Medicated Cold and Hot Patch
Active ingredientMENTHOL
Label structure9 sections

Dosage and administration

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Use one patch at a time. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of minor muscle and joint pain

Warning

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■Use only as directed

■Rare cases of serious burns have been reported with products of this type

■Don't bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes

■Don't apply to wounds or damaged skin

■Do not use at the same time as other topical analgesics.

When using this product

OTC - WHEN USING SECTION

Stop use and consult a doctor if

OTC - STOP USE SECTION

■ Condition worsens

■Redness is present

■Irritation develops
■Symptoms persist
for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Use one patch at a time. Repeat as necessary, but no more than 3 times daily. Discard patch after single use.
Reseal pouch after opening. Children under 12 years of age: consult a physician.

Other information

OTHER SAFETY INFORMATION

Store at room temperature, no to exceed 86F (30C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
Carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, glycerin, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions

OTC - QUESTIONS SECTION

Toll Free 1-866-723-3929

Signature Care Medicated Cold & Hot Patch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN4
420222menthol 0.05 MG/MG Medicated PatchSCD4
420222menthol 5 % Medicated PatchSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-987-05Signature Care Medicated Cold and Hot Patch9 g in 1 PATCHPATCH94
21130-987-05Signature Care Medicated Cold and Hot Patch5 in 1 CARTONPATCH54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-987SIGNATURE CARE MEDICATED COLD AND HOT PATCH (MENTHOL) PATCH [SAFEWAY]4Current NDC, 2 package rows20241222_0335f1b3-5c8a-67b8-e063-6294a90a9847.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-98721130-987-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Medicated Cold and Hot PatchMENTHOLSafeway0335f1b3-5c8a-67b8-e063-6294a90a98472024-12-19WarningsExact identifier
ndc (package): 21130-987-05
ndc (product): 21130-987
ndc11 (package): 21130098705
spl id: 29a69812-33bc-b04f-e063-6394a90ad206
spl set id: 0335f1b3-5c8a-67b8-e063-6294a90a9847

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.